Non-small Cell Lung Cancer
Conditions
Brief summary
This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive non-small cell lung cancer. The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707 is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.
Interventions
DRUGCT-707
Sponsors
Centaurus Biopharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients must be diagnosed with ALK-positive advanced NSCLC. The tumor must be ALK-positive as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis break-apart ALK probe) or by using the Ventana ALK IHC test. The analysis may be performed locally. Eastern cooperative oncology group (ECOG) performance status ≤ 2. Measurable disease as per RECIST v1.1 Availability of tumor sample:
Exclusion criteria
Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy to control their CNS disease Impaired cardiac function or any clinically significant cardiac disease Patients with abnormal laboratory values during screening and on day 1 of pre-dose Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CT-707 Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I) | 28 days | Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-707 in ALK-positive non-small cell lung cancer (NSCLC) patients. Cycle = 28 days |
| Frequency of adverse events/serious adverse events | Up to 24 months | Characterization of the safety and tolerability of CT-707 as determined by changes in laboratory values and electrocardiograms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) - Phase I | Up to 24 month | Preliminary measure of anti-tumor activity of CT-707 |
| Progression free survival (PFS) per RECIST v1.1 - Phase I | Up to 24 months | Preliminary measures of anti-tumor activity of CT-707 |
| Duration of response (DOR) | Up to 24 months | Preliminary measure of anti-tumor activity of CT-707 |
Countries
China
Contacts
Primary ContactYong Peng, Dr.
Outcome results
None listed